Pain-Relieving Patch For Tendonitis Praised

Action Points

Advise patients that this NSAID patch has not yet been approved by the Food and Drug Administration.

TOULOUSE, France, Aug. 18-An investigative patch containing the non-steroidal anti-inflammatory drug ketoprofen appeared safe and effective for treating tendonitis pain, according to a European study.

After one week of treatment, tendonitis pain decreased in the group treated with the patch by 56%, compared with 37% in the placebo group (P=.0013), said Bernard MaziÃ¨res, M.D., of the Rangueil University Hospital here, and colleagues in the August issue of the Journal of Rheumatology.

The multicenter, randomized, double-blinded, placebo-controlled trial included 127 patients with symptomatic tendonitis of recent onset not requiring orthopedic or surgical treatment. The 14-day study compared once-daily treatment with the patch, which delivers 100 mg of ketoprofen over 24 hours, to placebo. Pain on daily activities at day seven, reported by the patients on a visual analog scale, was the main outcome measure.

Day seven was the most accurate time point to assess efficacy because tendonitis usually resolves spontaneously in two or three weeks, the investigators said.

There were no grade 3 or 4 adverse events and no significant difference in the number of adverse events between the treatment and placebo group. The frequency of severe adverse events was higher in the ketoprofen group (21.7% versus 8.8% of all adverse events). The majority of adverse advents were local skin reactions, which resolved spontaneously within a week of discontinuing the patch and rarely led to premature discontinuation of treatment.

"This trial suggested that a three- to 14-day course of treatment by ketoprofen patch is useful in nonarticular rheumatisms, the duration of treatment depending on the results obtained, although seven days seems optimal," the researchers concluded.

The patch, which requires once daily application, may be more convenient for patients than topical gels containing NSAIDs that often require three or four applications daily, the investigators noted.

In addition, both topical gels and the patch may reduce the risk of gastrointestinal side effects associated with oral NSAIDs, they said. In the study, only 8% of the patients in the ketoprofen group experienced gastrointestinal side effects while 5.9% in the placebo group had similar side effects.

The study was conduced with support from the developer of the patch, Applied Pharma Research SA of Balerna, Switzerland. The Swiss company has licensed U.S. and Canadian marketing of the patch to ProEthic Pharmaceuticals Inc. of Montgomery, Ala. This company submitted an Investigational New Drug application for the patch to the FDA in January, and said it hopes to begin U.S. clinical trials later this year.

Reviewed by
Rubeen K Israni, MD, Fellow, Renal-Electrolyte and Hypertension Division, University of Pennsylvania School of Medicine

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